MindMed

Manager

• Function as an internal Lead Study Data Manager, independently overseeing all data management activities performed by CROs including database build, generation and review of metric status, and patient tracking reports to ensure major DM deliverables and milestones are delivered with high quality
• Represent Data Management on cross-functional study teams
• Oversee multiple concurrent studies while participating in special projects or process improvement initiatives
• Provide input to protocols and other clinical study documents during development; assist in review of vendor proposals, budgets, scopes of work
• Drive data management related study start up activities in collaboration with the CRO, including CRF design, manage sponsor’s database UAT, edit check specifications, data management plan, CCG’s and creation of vendor Data Transfer Agreements
• Manage all DM tasks as the clinical trial is ongoing, including data review/cleaning, SAE reconciliation, external data reconciliations, TMF plans, oversee migrations and database updates, review of protocol deviations, and oversee CRO’s DM team’s deliverables
• Play a critical leadership role in activities surrounding database lock to deliver high quality database lock meeting the timeline in collaboration with internal functions and the external vendors; tasks include final internal data review, queries closure, cross functional collaboration for issues’ resolution, and managing final external data transfers
• Perform ongoing review of study documentation in the trial master file (TMF) to ensure audit readiness
• Participate in development and implementation of departmental initiatives, review and provide input to SOPs and/or Working Instructions related to Clinical Data Management

Senior Manager, Data Management

Vice President

• Develop and execute a comprehensive market access strategy for MM120, securing formulary placement, reimbursement, and patient access across commercial, Medicare, and Medicaid payers, aligned with MindMed’s mission and regulatory landscape. Leverage industry best practices, such as early payer engagement and value-based contracting, to secure favorable coverage
• Establish and manage relationships with 3PL, wholesalers, and specialty pharmacies to ensure efficient, compliant, and scalable distribution of MM120
• Oversee the design and implementation of a patient-centric hub service model, emphasizing adherence and affordability tailored to mental health patients, to maximize access and support
• Ensure compliance with government pricing regulations (e.g., ASP, AMP, Medicaid, Medicare rebates, 340B), overseeing accurate reporting and strategic pricing decisions
• Lead GTN forecasting and analysis to optimize financial performance and inform pricing and contracting strategies
• Develop innovative pricing models and negotiate contracts with payers and GPO/PBMs to balance market penetration and profitability, drawing on proven strategies from specialty therapeutic launches
• Drive field-based market access initiatives, collaborating with sales and medical teams to ensure effective pull-through and stakeholder engagement
• Work closely with regulatory and medical teams to align market access strategies with REMS requirements for MM120, ensuring compliance and seamless integration without direct implementation responsibilities
• Leverage experience with DEA rescheduling processes to navigate regulatory complexities for controlled substances, ensuring market readiness
• Champion equitable patient access to MM120, addressing barriers through innovative reimbursement and support programs
• Build and mentor a high-performing, lean market access team suited for a startup environment, fostering collaboration, innovation, and accountability
• Collaborate with commercial, regulatory, medical, legal, and finance teams to align market access strategies with company goals
• Cultivate strong relationships with payers, PBMs, advocacy groups, and industry partners to enhance MindMed’s market presence
• Thrive in a fast-paced, resource-lean environment, driving results through agility, creative problem-solving, and a hands-on approach

Vice President, Market Access

QA Engineer

• Reports directly to the Associate Director of CMC QA, supporting CMC/GMP
• Review master batch records, master labeling/packaging records, product specifications and other process related documents from contract sites
• Perform batch record and data review/approval
• Review and/or approve deviations, OOSs, CAPAs, change control in an efficient manner for adequate and timely closeout of these events (internal and third party as relevant)
• Review and approve manufacturing and analytical validation protocols and reports.
• Support CMC QA document review, as assigned
• Assist in complaint investigations
• Review and approve product stability protocol and reports
• Assist in GMP Vendor audit and audit action completion. Schedule, conduct and provide timely reports of audits to assure conformance with the approved audit schedule, and to confirm compliance with regulations, guidelines, SOPs, and Industry standards
• Assist with Internal QA Audits, as assigned, ensuring timely conduct, reporting, and follow-up
• Perform initial and/or technical review of draft quality agreements prior to signatory review
• Utilize eQMS for quality workflows and for effective tracking, trending, and reporting of quality data and information
• Write, revise, and periodically review SOPs to further develop the Quality System and control over compliance and the quality of data, vendor services, and products
• Manage quality issues and investigations, root cause analyses, risk assessments and risk impact analyses, as well as corrective and preventive actions (CAPAs)
• Clearly communicate quality, compliance, and audit issues to internal and external parties, professionally, and in a timely manner
• Support Regulatory Compliance and Inspection Activities
• Participate in Computer System Validation and Testing
• Draft Validation documentation (protocols, reports) for eQMS workflows
• Review and sign off on validation and testing documentation
• Support GMP Vendor Document archival
• Develop and deliver, staff training on topics related to Quality, GxP Compliance, SOPs, and Risk Management
• Perform other quality assurance advisory duties as assigned by the Associate Director of CMC QA

Manager, CMC QA

Director

• Serve as Study Biostatistician for assigned clinical trials to provide statistical support from design, analysis to reporting
• Collaborate with cross-functional experts on clinical trial designs and make contributions to determination of objectives, endpoints and sample size
• Author statistical methods section in the protocol and review the protocol throughout
• Make certain the accuracy of randomization algorithm and contribute to eCRF design to ensure that study objectives, data analysis and data collection are aligned
• Be the primary owner of study statistical analysis plan (SAP) for the assigned clinical trials alongside the shells for table/figures/listing (TFL) that present the analytic results and reflect the analysis intent specified in the SAP
• Hold the primary responsibility of working with statistical vendors and internal Statistical Programming team to deliver study results with quality and speed
• Hold the primary responsibility of managing statistical vendors to deliver other data analyses as needed (e.g., DMC support, interim analysis)
• Provide statistical input to any form of data reporting or external dissemination, including clinical study report, regulatory communication and publication
• Conduct data analyses as needed by using own SAS programs in collaboration with internal Statistical Programming team

Associate Director, Biostatistics

Project Manager

• Manage activities within PPO and support interactions with other Departments, as delegated by department lead
• Lead the development of Project plan(s) to support functional areas such as Medial Affairs, QA, or to support Sr. Level PMs
• Help with system implementation to ensure awareness and alignment of project decisions, priorities, and key milestones
• Closely and proactively monitor the execution of the project plans and deliverables to ensure successful delivery of the program milestones, company milestones, and objectives

Project Manager – Program and Portfolio

• MindMed is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. Our mission is to be the global leader in the development and delivery of treatments that unlock new opportunities to improve patient outcomes.
• Founded in 2019, we are continuously expanding our presence and global footprint. We are constantly searching for high-impact individuals in various clinical, technical and business operations domains to strengthen our team of patient-centric, intelligent individuals.
• As Associate Director, Drug Substance Development you will be a technical leader and subject matter expert responsible for the synthetic route development, control strategy, scale-up, and supply from multiple CDMOs to meet program milestones. The ideal candidate will have a core expertise in small molecule synthesis and drug substance development experience from early development through commercialization.
• Responsibilities:
• Lead and direct drug substance synthetic route development, manufacturing control strategy, and scale-up at partner CDMOs
• Manage relationships with CDMOs to define and drive technical deliverables and ensure timely drug substance delivery to support pharmaceutical development and clinical trials
• Review and approve batch records, protocols, reports, and batch release and stability data
• Analyze/interpret data to support technical decision making, trend analysis, and root cause investigations
• Identify, mitigate, and document drug substance development, scale-up, and supply risks
• Effectively manage change controls, deviations, and CAPAs to expected quality standards
• Contribute to authoring of drug substance regulatory file sections
• Requirements:
• PhD or MS degree in organic chemistry or related discipline with a minimum of 6 years or 10 years, respectively, of pharmaceutical industry experience with demonstrated increasing responsibilities
• Strong working knowledge of current Good Manufacturing Practices (cGMPs) and Quality Systems
• Strong working knowledge of relevant regulatory requirements, pharmacopeias, and ICH guidance
• Subject matter expert in small molecule drug substance synthesis, scale-up, control strategies, and risk management
• Proven track record for partnering internally and externally to deliver Drug Substance development milestones on-time and right first time
• Ability to effectively collaborate, communicate, and influence in a cross-functional team environment
• Ability to work in a remote/hybrid environment
• Ability to travel domestically and internationally as needed
• The starting base pay range for this position is $157,262.00 - $185,491.00. Compensation will be determined based on several factors including, but not limited to, skill set, years of experience, and the employee’s geographic location.
• Employees in this role may be entitled to additional compensation, including bonus and equity. Benefits information is listed on our Jobs Page. The Company provides competitive benefits to employees including:
• 100% paid health benefits including Medical, Dental and Vision for you and your dependents
• 401(k) program with company match and immediate vesting
• Flexible time off
• Generous parental leave and some fun fringe perks!